Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage

NCT01615224 | Terminated Phase 2 DMC

• 1 other identifier: WMA11
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Missed abortion is a condition where the fetus has perished but the miscarriage is not expelled. Women often present at a routine ultrasound or with a slight brownish discharge. Traditionally this condition has been treated with curettage or vacuum aspiration. Lately, medical treatment has become more common due to less risk of infection and other complications. The routine medical treatment is 800mcg of misoprostol administered vaginally. We wish to examine of repeated doses of 400mcg misoprostol after the initial 800mcg vaginal misoprostol increases efficacy of the treatment.

Conditions

Missed Abortion

Keywords

missed abortion; miscarriage

Outcome Measures

Primary Outcomes (1)

• Efficacy

  Complete abortion as judged by ultrasound

  1 day

Secondary Outcomes (1)

• Acceptability

  1 day, 1 week, 2 weeks, 3 weeks, 5 weeks

Study Arms (2)

single dose

NO INTERVENTION

Patients receive the standard treatment with 800mcg of vaginal misoprostol

repeated doses

EXPERIMENTAL

patients receive 800mcg of vaginal misoprostol. In addition to this they receive repeated doses of 400mcg oral misoprostol after 3 and 5 hours. Women of more than 9 weeks pregnancy according to last menstrual period will be given a choice of vacuum aspiration or further medical treatment with 2 additional doses of misoprostol given after 7 and 9 hours after the initial vaginal treatment.

Drug: misoprostol

Interventions

misoprostol DRUG

repeated doses of misoprostol. 400mcg of oral misoprostol given at 3, 5, 7 and 9 hours.

Also known as: Cytotec 200mcg Pfizer

repeated doses

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• over 18 years of age healthy no contraindication to medical treatment visible fetal structures such as yolk sac or fetus

You may not qualify if:

• empty gestational sac more than sparse bleeding or dilated cervix mental instability after diagnosis contraindication to medical treatment

Sponsors & Collaborators

• Kristina Gemzell Danielsson: lead

Study Sites (1)

Dept of Obstetrics and Gynecology, Danderyd Hospital

Stockholm, 18288, Sweden

Location

MeSH Terms

Conditions

Abortion, Missed; Abortion, Spontaneous

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Kristina Gemzell Danielsson, professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 8, 2012
• Study Start: May 1, 2012
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-08

Locations

SE (1)